Bioequivalence and Bioavailability Forum

nobody nothing 2017-10-25 10:40 (2374 d 03:41 ago) Posting: # 17918 Views: 5,421	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? [Regulatives / Guidelines] Post reply
	Hy! Brand new FDA guideline on methylphenidate https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581432.pdf ...apparently they skipped this "subject-by-formulation" part of the thing... — Kindest regards, nobody

ElMaestro ★★★ Denmark, 2017-10-25 14:07 (2374 d 00:14 ago) @ nobody Posting: # 17919 Views: 4,559	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	Hi No-wan kenobi, ❝ ...apparently they skipped this "subject-by-formulation" part of the thing... What??!!!??! Are you seriously saying someone applied some degree of common sense in the guidance?? — Pass or fail! ElMaestro

Achievwin ★ US, 2017-10-26 18:35 (2372 d 19:45 ago) @ nobody Posting: # 17927 Views: 4,455	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	❝ ...apparently they skipped this "subject-by-formulation" part of the thing... Yes but partial areas are still there

jag009 ★★★ NJ, 2017-10-27 07:40 (2372 d 06:41 ago) @ Achievwin Posting: # 17931 Views: 4,474	FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? Post reply
	❝ Yes but partial areas are still there They wont get rid of that. J

jag009
★★★

NJ,
2017-10-27 07:39
(2372 d 06:42 ago)

@ nobody
Posting: # 17930
Views: 4,491

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

Post reply

❝ Brand new FDA guideline on methylphenidate

❝

❝ https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581432.pdf

❝

❝ ...apparently they skipped this "subject-by-formulation" part of the thing...

Yes for Ritalin SR. I've said it many times to people. That Sub-by-form interaction testing part is really only applicable to Concerta! If one tried to make sense of it.

J

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone? [Regulatives / Guidelines]

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?

FDA guide methylphenidate oral ER tablet - subject-by-formulation has gone?